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Keep this study
Lead
Medical University of South Carolina
Age
18–120
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Meets 1 of the following criteria:
* Measurable disease with any prostate-specific antigen (PSA) value
* Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* Histologic confirmation required if measurable disease is confined to a solitary lesion
* Non-measurable disease with PSA ≥ 5 ng/mL\*
* The following are considered non-measurable disease:
* Bone lesions
* Pleural or pericardial effusion
* Ascites
* CNS lesions
* Leptomeningeal disease
You may not be if
Progressive systemic disease despite ≥ 1 prior standard endocrine therapy with orchiectomy, luteinizing hormone-releasing hormone (LHRH) agonist, or diethylstilbestrol, as indicated by 1 of the following criteria:
* Objective evidence of increase \> 20% in the sum of the longest diameters of target lesions from the time of maximal regression OR the appearance of 1 or more new lesions
* One or more new lesions on bone scan secondary to prostate cancer AND PSA ≥ 5 ng/mL
* Elevated PSA (≥ 5 ng/mL) with 2 consecutive increases from baseline (taken ≥ 1 week apart)
Serum testosterone ≤ 50 ng/dL for patients without bilateral orchiectomy
* Patients who have not had a bilateral orchiectomy should continue therapy with primary testicular androgen suppression (e.g., LHRH analogues)
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
ECOG 0-2
Life expectancy
Not specified
Hematopoietic
Granulocyte count ≥ 1,500/mm\^3
Platelet count ≥ 100,000/mm\^3
Hepatic
Meets 1 of the following criteria:
* AST or ALT normal AND alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
* AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
* AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal
Bilirubin normal
Renal
Creatinine ≤ 1.5 times ULN
Cardiovascular
No uncontrolled high blood pressure
No unstable angina
No symptomatic congestive heart failure
No myocardial infarction within the past 6 months
No serious uncontrolled cardiac arrhythmia
No New York Heart Association class III or IV heart disease
Other
Fertile patients must use effective contraception during and for at least 3 months after study participation
No peripheral neuropathy ≥ grade 2
No prior severe hypersensitivity reaction to docetaxel or other drug formulated with polysorbate 80
PRIOR CONCURRENT THERAPY:
Biologic therapy
No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
No prior chemotherapy, including estramustine or suramin for prostate cancer
No other concurrent chemotherapy
Endocrine therapy
See Disease Characteristics
At least 4 weeks since prior antiandrogen therapy
No concurrent hormonal therapy except steroids for adrenal insufficiency, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
Radiotherapy
See Disease Characteristics
At least 4 weeks since prior radiotherapy
At least 8 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
No concurrent palliative radiotherapy
Surgery
See Disease Characteristics
At least 4 weeks since prior surgery and recovered
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